KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT— 510(k) K111970

Name: FDA 510(k) clearance K111970
Creator: U.S. Food and Drug Administration
Published: 2012-02-23

Substantially Equivalent

Tornier

FDA 510(k) clearance K111970 for KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT, Substantially Equivalent on 2012-02-23. Applicant: Tornier. Device class: 2.

Clearance details

Applicant: Tornier
Product code: Code KRR
Device class: Class 2
Regulation: 21 CFR 888.3540
Advisory panel: Orthopedic
Date received: 2011-07-11
Decision date: 2012-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Ismier Cedex, FR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.